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Hip FracturesNCT04063891

Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients

A study testing Low-magnitude high-frequency vibration (LMHFV) in people with Hip Fractures, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year. In Hong Kong, around 6,000 hip fractures occur yearly with costs approximately 52 million USD, and these numbers are projected to double by 2050. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hip Fractures
What is being tested?
Low-magnitude high-frequency vibration (LMHFV)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
1 siteHong Kong
Study dates
6 Sep 2021to 31 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Elderly male or females aged 65 years or older
  • Unilateral trochanteric hip fractures (AO classification A1-A3)
  • Due to unintentional fall
  • Fractures fixed with cephalomedullary nail (Gamma nail, Stryker - usual practise at our unit)
  • Willing and able to comply with study protocol

Who cannot join

  • Open fracture
  • Bilateral fractures
  • Patient with multiple injuries
  • Pathological fractures e.g. tumour, infection, etc.
  • History of medication or disease affecting bone metabolism such as hypo/hyperthyroidism, hypo/hyperparathyroidism, etc.
  • Malignancy
  • Chairbound or bedbound (unable to comply for LMHFV therapy)
  • Cognitive problems e.g. dementia (unable to agree for consent)

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Ronald Man Yeung Wong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients: A Randomized Double-Blinded, Placebo-Controlled Clinical Trial

Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year. In Hong Kong, around 6,000 hip fractures occur yearly with costs approximately 52 million USD, and these numbers are projected to double by 2050.

The treatment of osteoporotic fractures is a major challenge as bone healing is delayed due to the impaired healing properties with respect to bone formation, angiogenesis and mineralization. Failure to unite results in pain, weakness, reduced mobility and fixation failure, and these complications are most common in elderly patients. Enhancement of osteoporotic fracture healing even after surgical fixation is therefore critical as a major goal in modern fracture management.

Read more

Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and we are the first group to study its effect on fracture healing. Our previous animal studies have shown LMHFV to enhance healing from the early inflammation stage to the late phases of remodeling in osteoporotic diaphyseal fracture healing. Using our newly developed clinically relevant metaphyseal fracture model, we further proved the efficacy of LMHFV. Our results show LMHFV significantly enhanced fracture healing in both osteoporotic and normal rats radiologically by X-ray and micro-CT, histologically and biomechanically.

Justified with our preclinical studies, we hypothesize LMHFV can accelerate the time to fracture healing and enhance functional recovery. In this study, we propose to study the efficacy of LMHFV in trochanteric hip fracture healing by conducting a randomized double-blinded placebo-controlled clinical trial. Elderly patients aged 65 years or older of either gender, after surgical fixation, will be treated with LMHFV at 35Hz, 0.3g, 20 minutes/day, 5 days/week for 6 months. Results will be evaluated by clinical assessments, radiologically with X-rays, Computed Tomography (CT) and dynamic perfusion Magnetic Resonance Imaging (MRI) for blood circulation evaluation, Dual-energy X-ray absorptiometry (DXA), functional outcomes, and mortality. Positive findings from the study would have huge impact and change clinical practice.

Read the detailed description

Osteoporosis predisposes patients to increased risk of fragility fractures, which affects clinical outcomes and functional recovery. In fact, the lifetime fracture risk of osteoporotic patients reaches as high as 40%. There are approximately 2.5 million osteoporotic fractures each year in the United States (US), with costs estimated at $15 billion USD in 2010. Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year.

Low-magnitude high-frequency vibration (LMHFV) is a promising biophysical intervention that provides non-invasive, systemic mechanical stimulation. We previously conducted a randomized controlled trial with 710 healthy, active and independent postmenopausal women over 60 years old. The LMHFV group had significant improvements in reaction time, movement velocity, maximum excursion of balancing ability assessment and also quadriceps muscle strength (p<0.001). There were significantly lower fall incidences with 18.6% of 334 vibration group subjects compared with 28.7% of 327 control group subjects (adjusted HR=0.56, p=0.001). Benefits of LMHFV for balancing ability, muscle strength and risk of falling were retained 1 year after cessation of the treatment.

This is a randomized double-blinded placebo-controlled clinical trial to investigate the use of LMHFV to enhance trochanteric hip fracture healing and will provide impactful findings for the future management of osteoporotic fractures.

Objectives

  1. To investigate the efficacy of LMHFV in trochanteric hip fractures on the time to radiological healing by conducting a randomized double-blinded placebo-controlled controlled clinical trial
  2. To assess the effects of LMHFV in trochanteric hip fractures compared with control on clinical outcomes, densitometry, blood circulation, and mortality

Research Plan and Methodology A total of 120 unilateral trochanteric hip fracture (AO classification A1-A3) patients due to unintentional fall, aged 65 years or older, will be recruited. Patients will be randomized into either vibration or placebo group after surgical fixation with a cephalomedullary nail. Radiology will be taken after fixation and regular follow-up X-rays will be taken. CTs will also be taken to assess fracture healing. Blood circulation will be assessed by dynamic perfusion MR. BMD and Bone mineral content (BMC) at fracture site will be measured by Dual X-ray Absorptiometry (DXA) scan. Clinically, vital signs, wound condition and pain intensity will be monitored. Functional outcomes including Short Form-36 (SF-36), muscle strength, Timed up and go (TUG) test and balancing ability are evaluated. Mortality will be documented. Throughout the study, complications and safety issues will be documented and in case adverse events occur, treatment will be terminated immediately. The above parameters will be compared between pre- and post-treatment and between the 2 groups.

Conditions
Hip Fractures
Being tested
Low-magnitude high-frequency vibration (LMHFV)
Keywords
Fracture healing, Osteoporosis, Vibration treatment
Medical subject headings
Hip Fractures, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-magnitude high-frequency vibration (LMHFV)Device

    Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been reported to have no adverse effect.

  • Low-magnitude high-frequency vibration (LMHFV)Device

    Placebo group will have sham treatment by standing on the LMHFV platform for 20 minutes/day

Study groups in NCT04063891
Study groupRoleWhat they receive
Placebo-ControlledPlacebo comparatorPlacebo group will have placebo treatment by standing on the LMHFV platform for 20 minutes/day
Receives: Device: Low-magnitude high-frequency vibration (LMHFV)
Vibration GroupExperimentalVibration group is treated with LMHFV at 35Hz, 0.3g, for 20 minutes/day, 5 times/week
Receives: Device: Low-magnitude high-frequency vibration (LMHFV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in time to healing

    X-ray

    Measured: X-ray: baseline, 12, 52 weeks post-operation

  2. Change in time to healing

    Computed Tomography

    Measured: 6 weeks post-operation

Secondary outcomes (9)
  1. Densitometry

    Bone Mineral Density

    Measured: baseline, 6, 12 and 26 weeks post-operation

  2. Densitometry

    Bone mineral content

    Measured: baseline, 6, 12 and 26 weeks post-operation

  3. Blood circulation at fracture site

    Measured by dynamic contrast-enhanced MR imaging

    Measured: 6 weeks post-operation

  4. Pain scale

    Verbal Descriptor Scale (Pain Thermometer): scale ranges from 0 to 10, higher score indicates more pain

    Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation

  5. Quality of life questionnaire (SF-36)

    Functional status questionnaire to measure health-related quality of life in eight domains (physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health; Scores ranges from 0-100, higher score indicates better result.

    Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation

  6. Quadriceps muscle strength

    Dynamometer

    Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation

  7. Balancing ability

    Basic Balance Master System

    Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation

  8. Time up and go test (TUG)

    The subject will stand from a chair, walk 3 meters and travel back and sit back on the chair. The time is recorded

    Measured: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation

  9. Mortality

    Measured: 1 month, 3 months and 1 year post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2019
  2. Study start6 Sep 2021
  3. Primary completion6 Sep 2024
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Double-Blinded, Placebo-Controlled Clinical Trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04063891
Sponsor's protocol ID
2018.584
Status last verified
May 2025
First submitted
18 Aug 2019
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rachner TD, Khosla S, Hofbauer LC. Osteoporosis: now and the future. Lancet. 2011 Apr 9;377(9773):1276-87. doi: 10.1016/S0140-6736(10)62349-5. Epub 2011 Mar 28.

    PubMed 21450337
  • Solomon DH, Patrick AR, Schousboe J, Losina E. The potential economic benefits of improved postfracture care: a cost-effectiveness analysis of a fracture liaison service in the US health-care system. J Bone Miner Res. 2014 Jul;29(7):1667-74. doi: 10.1002/jbmr.2180.

    PubMed 24443384
  • Black DM, Rosen CJ. Postmenopausal Osteoporosis. N Engl J Med. 2016 May 26;374(21):2096-7. doi: 10.1056/NEJMc1602599. No abstract available.

    PubMed 27223157
  • Shi HF, Cheung WH, Qin L, Leung AH, Leung KS. Low-magnitude high-frequency vibration treatment augments fracture healing in ovariectomy-induced osteoporotic bone. Bone. 2010 May;46(5):1299-305. doi: 10.1016/j.bone.2009.11.028. Epub 2009 Dec 2.

    PubMed 19961960
  • Bow CH, Tsang SW, Loong CH, Soong CS, Yeung SC, Kung AW. Bone mineral density enhances use of clinical risk factors in predicting ten-year risk of osteoporotic fractures in Chinese men: the Hong Kong Osteoporosis Study. Osteoporos Int. 2011 Nov;22(11):2799-807. doi: 10.1007/s00198-010-1490-0. Epub 2011 Jan 14.

    PubMed 21234548
  • Cheung WH, Sun MH, Zheng YP, Chu WC, Leung AH, Qin L, Wei FY, Leung KS. Stimulated angiogenesis for fracture healing augmented by low-magnitude, high-frequency vibration in a rat model-evaluation of pulsed-wave doppler, 3-D power Doppler ultrasonography and micro-CT microangiography. Ultrasound Med Biol. 2012 Dec;38(12):2120-9. doi: 10.1016/j.ultrasmedbio.2012.07.025. Epub 2012 Oct 11.

    PubMed 23062367
  • Leung KS, Yuen WF, Ngai WK, Lam CY, Lau TW, Lee KB, Siu KM, Tang N, Wong SH, Cheung WH. How well are we managing fragility hip fractures? A narrative report on the review with the attempt to setup a Fragility Fracture Registry in Hong Kong. Hong Kong Med J. 2017 Jun;23(3):264-71. doi: 10.12809/hkmj166124. Epub 2017 May 5.

    PubMed 28473651
  • Leung KS, Shi HF, Cheung WH, Qin L, Ng WK, Tam KF, Tang N. Low-magnitude high-frequency vibration accelerates callus formation, mineralization, and fracture healing in rats. J Orthop Res. 2009 Apr;27(4):458-65. doi: 10.1002/jor.20753.

    PubMed 18924140
  • Chung SL, Leung KS, Cheung WH. Low-magnitude high-frequency vibration enhances gene expression related to callus formation, mineralization and remodeling during osteoporotic fracture healing in rats. J Orthop Res. 2014 Dec;32(12):1572-9. doi: 10.1002/jor.22715. Epub 2014 Aug 17.

    PubMed 25131218
  • Chow DH, Leung KS, Qin L, Leung AH, Cheung WH. Low-magnitude high-frequency vibration (LMHFV) enhances bone remodeling in osteoporotic rat femoral fracture healing. J Orthop Res. 2011 May;29(5):746-52. doi: 10.1002/jor.21303. Epub 2010 Dec 23.

    PubMed 21437955
  • Wei FY, Chow SK, Leung KS, Qin J, Guo A, Yu OL, Li G, Cheung WH. Low-magnitude high-frequency vibration enhanced mesenchymal stem cell recruitment in osteoporotic fracture healing through the SDF-1/CXCR4 pathway. Eur Cell Mater. 2016 May 24;31:341-54. doi: 10.22203/ecm.v031a22.

    PubMed 27215741
  • Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.

    PubMed 24676848
  • Cheung WH, Li CY, Zhu TY, Leung KS. Improvement in muscle performance after one-year cessation of low-magnitude high-frequency vibration in community elderly. J Musculoskelet Neuronal Interact. 2016 Mar;16(1):4-11.

    PubMed 26944817
  • Griffith JF. Functional imaging of the musculoskeletal system. Quant Imaging Med Surg. 2015 Jun;5(3):323-31. doi: 10.3978/j.issn.2223-4292.2015.03.07.

    PubMed 26029633
  • Griffith JF, Genant HK. New imaging modalities in bone. Curr Rheumatol Rep. 2011 Jun;13(3):241-50. doi: 10.1007/s11926-011-0174-x.

    PubMed 21369797

Questions about this trial

What is this clinical trial studying?

A study testing Low-magnitude high-frequency vibration (LMHFV) in people with Hip Fractures, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in time to healing (time frame: X-ray: baseline, 12, 52 weeks post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04063891, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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